背景:在高资源设置中,血管生成平衡的生物标志物,如可溶性fms样酪氨酸激酶-1(sFlt1)/胎盘生长因子(PlGF)的比例,已经进行了广泛的研究,以帮助评估怀疑先兆子痫(PE)的患者,并已纳入2021年国际妊娠高血压研究学会对PE的定义。资源不足设置中的实用程序尚未得到很好的表征。
目的:本分析旨在确定sFlt1/PlGF比值在有或无高血压患者评估中的作用,这些患者被怀疑患有PE而没有其他诊断信息。
方法:这是对先前一项前瞻性研究的二级分析,这些研究对象是在单一学术三级护理中心妊娠≥20+0周时出现疑似PE的患者。在2009年7月至2012年6月的父母研究中招募了患者。在最初的研究中,临床医生掩盖了生物标志物的结果,并对患者进行图表回顾。在这个分析中,单独评估sFlt1/PlGF比值(≤38,>38或>85)在分诊访视(PE-SF2)后2周内鉴别有发展为具有严重特征的PE风险(PE-SF;美国妇产科学院定义)的高血压和非高血压患者的表现.高血压定义为血压(BP)≥140/90mmHg。
结果:分析纳入1043例患者,579(55.5%)和464(44.5%)伴有或不伴有高血压,分别。在分诊中,332(75.4%)的高血压患者因血压问题而出现,其余的由于其他特征(新发头痛,蛋白尿,或水肿)。关于分诊评估,所有患者中66.8%的sFlt1/PlGF比值正常≤38,17.0%的比值升高>85。在高血压患者中,sFlt1/PlGF比值≤38是PE-SF2的良好排除测试(负似然比[LR-]为0.15),比率>85是一个良好的规则检验(正似然比[LR+]为5.75)。在血压正常的患者中,sFlt1/PlGF可用作比率>38(LR+5.13)和>85(LR+12.80)的规则检验。按胎龄分层,sFlt1/PlGF在<35周的高血压患者中仍然是良好的规则和良好的排除测试,但在≥35周的测试表现不佳。sFlt1/PlGF在>85的测试中通常具有良好的测试性能,而与孕龄无关。在分诊中,4.3%(30/693)sFlt1/PlGF比值<38的患者同时有PE的实验室证据,15.9%(28/176)的患者比例>85。
结论:这些发现支持在资源有限的环境中单独使用sFlt1/PlGF和BP测量的潜力,在这些环境中,其他实验室测试或临床专业知识无法用于风险分层。生物标志物的性能因高血压的存在和胎龄而异。
BACKGROUND: In high-resource settings, biomarkers of angiogenic balance, such as the soluble fms-like tyrosine kinase-1 (sFlt1)/placental growth factor (PlGF) ratio, have been studied extensively to aid in evaluation of patients with suspected preeclampsia (PE), and have been incorporated into the 2021 International Society for the Study of Hypertension in Pregnancy definition of PE. The utility in under-resourced settings has not been as well characterized.
OBJECTIVE: This analysis sought to identify the role of the sFlt1/PlGF ratio in the evaluation of patients with or without hypertension who are suspected of having PE without other diagnostic information.
METHODS: This is a secondary analysis of a prior prospective study of patients who were presented with suspected PE at ≥20+0 weeks\' gestation at a single academic tertiary care center. Patients were recruited in the parent study from July 2009 to June 2012. In the original study, clinicians were masked to biomarker results, and patients were followed by chart review. In this analysis, the performance of the sFlt1/PlGF ratio (≤38, >38, or >85) was assessed alone in identifying both hypertensive and non-hypertensive patients at risk of evolving into PE with severe features (PE-SF; American College of Obstetricians and Gynecologists\' definition) within two weeks of the triage visit (PE-SF2). Hypertension was defined as a blood pressure (BP)≥140/90 mmHg.
RESULTS: There were 1043 patients included in the analysis; of whom, 579 (55.5%) and 464 (44.5%) presented with or without hypertension, respectively. In triage, 332 (75.4%) of hypertensive patients presented due to BP concerns, and the remainder were evaluated due to other features (new-onset headache, proteinuria, or edema). On triage evaluation, 66.8% of all patients had a normal sFlt1/PlGF ratio ≤38, and 17.0% had an elevated ratio >85. Among hypertensive patients, a sFlt1/PlGF ratio ≤38 was a good rule-out test for PE-SF2 (negative likelihood ratio [LR-] of 0.15), and a ratio >85 was a good rule-in test (positive likelihood ratio [LR+] of 5.75). Among normotensive patients, sFlt1/PlGF was useful as a rule-in test for ratio >38 (LR+ 5.13) and >85 (LR+ 12.80). Stratified by gestational age, sFlt1/PlGF continued to be a good rule in and good rule out test at <35 weeks among those with hypertension but did not have good test performance ≥35 weeks. sFlt1/PlGF had a good test performance as a rule in test for >85 regardless of gestational age. In triage, 4.3% (30/693) of patients with sFlt1/PlGF ratio <38 had concurrent laboratory evidence of PE, compared with 15.9% (28/176) patients with ratio >85.
CONCLUSIONS: These findings support the potential for the use of sFlt1/PlGF and BP measurement alone in resource-limited settings where other laboratory tests or clinical expertise are unavailable for risk stratification. Performance of the biomarker varied by the presence of hypertension and gestational age.